Clinical Trials Logo

Clinical Trial Summary

Study investigating the guiding catheter Selectra 3D


Clinical Trial Description

The guiding catheter 'Selectra 3D' is a catheter that is intended to support the implantation of a pacemaker lead in untypical positions in the heart like in the His- bundle area. This study is designed as post market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the guiding catheter Selectra 3D that remained unrevealed even after risk analysis, risk mitigation and successful conformity assessment. Moreover, the study aims at providing additional PMCF data, as required by regulatory authorities. Furthermore, the performance and efficacy of the Selectra 3D shall be assessed. The results will be used for updating the clinical evaluation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04323670
Study type Interventional
Source Biotronik SE & Co. KG
Contact
Status Completed
Phase N/A
Start date October 8, 2020
Completion date December 22, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05015660 - Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing N/A
Recruiting NCT02931760 - Placement Of Cardiac PacemaKer Trial (POCKET)-RCT N/A
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A
Not yet recruiting NCT06045143 - Right Ventricular Septal Versus Apical Pacing: Echocardiographic Study
Completed NCT04163965 - Data Collection for Pacemaker Recognition Through Capacitive ECG N/A
Not yet recruiting NCT06377046 - Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial N/A
Completed NCT04269733 - Risk of Pacing-induced Cardiomyopathy
Completed NCT06068699 - Postcards to Improve Remote Monitoring Adherence Among Veterans N/A
Recruiting NCT05868616 - Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Recruiting NCT06371846 - Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices
Recruiting NCT03357926 - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Recruiting NCT05884359 - Left Bundle Branch Area Mapping for Conduction System Pacing
Completed NCT04372654 - Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients N/A
Not yet recruiting NCT05695534 - Use of VR in Patients' Education Prior to Implantation of PPM N/A
Completed NCT04067024 - Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker N/A
Recruiting NCT06318130 - Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes N/A
Recruiting NCT04416958 - Pacing to Maintain Physiologic Ventricular Activation
Completed NCT05222672 - Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem
Enrolling by invitation NCT04383392 - QoL Between CIEDs With and Without Rate Adaptive Pacing N/A
Completed NCT04957771 - Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation N/A